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AzTrials

Esophageal CarcinomaNeo-DRATECNCT03381651

Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

A study testing Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation and Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation in people with Esophageal Carcinoma and Neoadjuvant Chemoradiotherapy, run by Zhejiang Cancer Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation and Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
2 sitesChina
Study dates
22 Feb 2018to 22 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age:18-70 years
  • Histologically verified squamous carcinoma of the thoracic esophagus.
  • Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
  • Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.
  • Joined the study voluntarily and signed informed consent form
  • No surgical contraindications
  • No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN

Who cannot join

  • Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).
  • Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.
  • Invasion of the tracheobronchial tree or aorta
  • Tracheoesophageal fistula
  • Concurrent pregnancy or lactation
  • Severe diabetes mellitus with poor blood glucose control
Show all 10Show fewer
  • History of a second malignancy
  • Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.
  • Patients undergoing esophageal reconstruction with jejunum.
  • Patients have allergy reaction or contraindications to taxanes.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Different Radiation Dose of Neoadjuvant Chemoradiation Followed by Surgery in Treating Patients with Locally Advanced, Resectable Thoracic Esophageal Cancer

Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages.

In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown.

The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.

Being tested
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation, Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation
Keywords
Radiation dose
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Higher dose (50.4Gy/28F) of neoadjuvant chemoradiationRadiation

    50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly

  • Lower dose (41.4Gy/23F) of neoadjuvant chemoradiationRadiation

    41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly

Study groups in NCT03381651
Study groupRoleWhat they receive
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiationActive comparatorNeoadjuvant chemoradiation: RT: 50.4Gy/28F/5.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 6 wks; Surgery: 4-6 weeks after nCRT
Receives: Radiation: Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation
Lower dose (41.4Gy/23F) of neoadjuvant chemoradiationActive comparatorNeoadjuvant chemoradiation: RT: 41.4Gy/23F/4.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 5 wks; Surgery: 4-6 weeks after nCRT
Receives: Radiation: Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Time from randomization to tumor progression or any deaths

    Measured: 2 year

Secondary outcomes (5)

  1. R0 resection rate in each arm

    no cancer cells seen microscopically at the resection margin

    Measured: analysis is completed 4 weeks after surgery

  2. Complete pathological response rate

    using the Chirieac grading system

    Measured: analysis is completed 4 weeks after surgery

  3. Postoperative complications in each study arm

    According to the NCI CTC3.0

    Measured: 30 and 90 days after surgery

  4. Treatment failure pattern

    including local recurrence or distant metastasis or both

    Measured: 2 year

  5. Overall survival

    by intention to treat and per protocol analyses in each study arm

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2017
  2. Study start22 Feb 2018
  3. Primary completion22 Feb 2021
  4. Study completion22 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381651
Sponsor's protocol ID
ZhejiangEC5040
Acronym
Neo-DRATEC
Status last verified
Mar 2022
First submitted
18 Dec 2017
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.

    PubMed 21684205

  • Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.

    PubMed 26254683

  • Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593.

    PubMed 18309943

  • Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.

    PubMed 17329193

  • Noordman BJ, Verdam MGE, Lagarde SM, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch OR, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A, Sprangers MAG, van Lanschot JJB. Effect of Neoadjuvant Chemoradiotherapy on Health-Related Quality of Life in Esophageal or Junctional Cancer: Results From the Randomized CROSS Trial. J Clin Oncol. 2018 Jan 20;36(3):268-275. doi: 10.1200/JCO.2017.73.7718. Epub 2017 Nov 21.

    PubMed 29161204

  • van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

    PubMed 22646630

  • Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.

    PubMed 22887465

Questions about this trial

What is this clinical trial studying?

A study testing Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation and Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation in people with Esophageal Carcinoma and Neoadjuvant Chemoradiotherapy, run by Zhejiang Cancer Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03381651, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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